NCT05862545

Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)

Outcomes in Real-life After Initation Of treatmeNt With Trixeo (Budesonide / Glycopyrronium / Formoterol), a Non-interventional, Multi-centre, Prospective Cohort Study in Italian Routine Care Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation, up to one year of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment. This will allow to assess the short-term impact of treatment, thus contributing to fill the gap of knowledge from the current available medical literature. Moreover, in order to provide also a broader view, patients will be followed up to 52 weeks, where possible. The study results will be interpreted in the context of an observational study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Detailed description

The therapeutic goal of chronic obstructive pulmonary disease (COPD) management is mainly reduction of symptoms and severity of exacerbations.Triple therapy (the combination of an ICS, a LABA and a LAMA) in a single fixed-dose combination is a valuable development in the treatment of COPD. On top of treatment adherence enhancement \[Gaduzo et al., 2019\], trials showed triple therapy improving lung function, Patients-Reported Outcomes (PROs), health-related quality of life, as well as lowering exacerbations and hospitalization rate compared to dual or mono-therapy \[Bourbeau et al., 2021; Zheng et al, 2018\]. Budesonide/glycopyrrolate/formoterol fumarate, hereafter BGF, is a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LABA and a LAMA. The availability of single-inhaler triple therapies in routine care may improve symptoms control, reduce exacerbation rate and COPD-related healthcare costs, thus leading to an improvement in patient health status and quality of life. However, real-world studies focusing on PROs are still limited. The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation, up to one year of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment. This will allow to assess the short-term impact of treatment, thus contributing to fill the gap of knowledge from the current available medical literature. Moreover, in order to provide also a broader view, patients will be followed up to 52 weeks, where possible. The study results will be interpreted in the context of an observational study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	BGF (budesonide/glycopyrrolate/formoterol fumarate)	BGF is a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LABA and a LAMA. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-05-17
• Last updated: 2026-03-18

Locations

20 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study